Fluid Intolerance Signals as Safety Limits to Prevent Fluid-induced Harm During Septic Shock Resuscitation

The goal of this multicentric randomized controlled trial is to compare, in septic shock patients who require further fluid resuscitation, two strategies of administering fluids. The intervention group will integrate fluid intolerance signals to the decision making process, while the control group will follow standard of care, for a 6 hour study protocol. The main question it aims to answer is 1. To compare the effect of both resuscitation strategies on fluid-induced harm, assessed by the change in pulmonary, cardiac, and renal function biomarkers during the study period. 2. To assess the safety of both resuscitation strategies on hypoperfusion resolution, measured by the improvement of capillary refill time (CRT) and lactate during the study period. 3. To determine the dynamics of the different fluid intolerance signals

NCT Number	NCT06568744
Lead Sponsor	Pontificia Universidad Catolica de Chile
Conditions	Septic Shock
Enrollment	62 participants
Start Date	2024-08-22
Primary Completion	2026-05 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2024-10-02